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NCT ID: NCT01056822 Completed - Clinical trials for Prophilaxis of Acute Rejection in Patients Receiving a Renal Allograft

Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate Sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate Mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.

MAXIMIZA
Start date: May 2010
Phase: Phase 4
Study type: Interventional

Multicenter, Randomized, Open-label Study to Assess Whether Treatment With Mycophenolate sodium (MPS) Allows Higher Dose Optimization Versus Mycophenolate mofetil (MMF) Leading to a Dose Reduction of Tacrolimus. Maximiza Study.

NCT ID: NCT01056510 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)

Start date: March 2010
Phase: Phase 4
Study type: Interventional

This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.

NCT ID: NCT01056471 Completed - Autoimmune Diseases Clinical Trials

Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis

Start date: January 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.

NCT ID: NCT01056354 Completed - Clinical trials for Influenza and Other Novel Respiratory Viruses

Respiratory Virus Outpatient Study (FLU 002 Plus)

Start date: August 2009
Phase: N/A
Study type: Observational

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded

NCT ID: NCT01056341 Completed - Clinical trials for Infantile Hemangioma

Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

Start date: January 2010
Phase: Phase 2/Phase 3
Study type: Interventional

There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

NCT ID: NCT01056120 Completed - Clinical trials for De Novo and Re-stenosed Coronary Artery Lesions

Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice

ENERGY
Start date: March 2010
Phase: N/A
Study type: Observational

To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.

NCT ID: NCT01055405 Completed - COPD Clinical Trials

Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension

SIL-COPD-02
Start date: August 2008
Phase: Phase 4
Study type: Interventional

Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.

NCT ID: NCT01054573 Completed - Clinical trials for Hepatitis C, Chronic

VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

Start date: April 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

NCT ID: NCT01053715 Completed - Hemophilia A Clinical Trials

Quality of Life Study of Helixate NexGen

Start date: January 2010
Phase: N/A
Study type: Observational

The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The study will also assess the kinds of determinants, including key transitional life events, that might impact HRQoL in this patient population.

NCT ID: NCT01052402 Completed - Influenza, Avian Clinical Trials

Safety and Immunogenicity Study of a H5N1 Influenza Vaccine (Vero Cell-Derived, Whole Virus) in Healthy Infants, Children and Adolescents

Start date: December 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and immunogenicity (i.e. primary immune response, immunogenicity of two different doses, antibody persistence 360 days after the first vaccination, immune response to a heterologous booster given on Day 360) of a Vero cell-derived whole virus H5N1 influenza vaccine in healthy infants, children and adolescents aged 6 months to 17 years.